Post-market surveillance is critical for diabetic test strips due to the biological nature of the enzymes used, which causes inherent Lot-to-Lot Variability. Historically, this variability was managed by users manually entering calibration codes; modern systems use Auto-Coding (on-strip resistors) or high-precision manufacturing to eliminate this step. The industry standard for accuracy is ISO 15197, requiring 95% of readings to be within ±15% of reference values.

To address gaps in FDA pre-market clearance, the Diabetes Technology Society (DTS) established an independent surveillance program that tests strips purchased from retail channels, revealing that while top-tier OEMs generally maintain compliance, many low-cost generics fail to meet accuracy standards in the real world. Major safety incidents, such as the GDH-PQQ maltose interference fatalities, highlight the necessity of rigorous post-market monitoring to detect chemical interferences and stability issues (e.g., humidity damage) that occur after the product leaves the factory.